Actively Recruiting
Prospective Randomized Comparative Study Evaluating Outcomes After Thulium Laser Enucleation of the Prostate Versus Holmium Laser Enucleation of the Prostate
Led by Ludwig-Maximilians - University of Munich · Updated on 2026-05-07
150
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Benign prostatic hyperplasia (BPH) is a common condition in older men where an enlarged prostate causes urinary problems such as weak stream, frequent urination, and incomplete bladder emptying. This trial evaluates two laser surgery techniques, Holmium Laser Enucleation of the Prostate (HoLEP) and Thulium Laser Enucleation of the Prostate (ThuLEP), to see if ThuLEP is as effective as HoLEP in improving urinary symptoms and to compare recovery and complication rates. The study is a prospective, randomized, single-blind trial involving men with clinically relevant BPH who need surgery. Participants will be randomly assigned to either the ThuLEP or HoLEP procedure. Both are established surgical treatments using laser energy to remove enlarged prostate tissue, with ThuLEP using a pulsed thulium laser and HoLEP using a holmium:YAG laser. Surgery is performed following standard procedures, and participants are unaware of which technique they receive. After surgery, follow-up visits will occur at discharge and at 3, 6, and 12 months, where various health measures are assessed. Throughout the study, participants complete questionnaires on urinary symptoms, continence, and erectile function, and undergo tests such as uroflowmetry and residual urine measurement before surgery and during follow-up visits. Researchers monitor operative details, complications, and the need for further interventions over 12 months. The main outcome is the change in urinary symptoms measured by the International Prostate Symptom Score (IPSS) at 12 months after surgery.
CONDITIONS
Brief Title
HoLEP-ThuLEP - Comparing Lasers for BPH Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, age 18 years or older
- Clinically relevant benign prostatic syndrome with an indication for surgery
- International Prostate Symptom Score (IPSS) of 8 or higher
- Prostate volume greater than 40 ml
- Signed written informed consent
You will not qualify if you...
- Proven or suspected prostate cancer
- Previous surgery of the prostate or urethra
- Neurogenic bladder dysfunction
- Anticoagulation therapy that cannot be paused around surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Typically up to 7 days
Participants undergo either Thulium Laser Enucleation of the Prostate (ThuLEP) or Holmium Laser Enucleation of the Prostate (HoLEP) surgery followed by immediate post-operative care during the hospital stay.
1 visit (day of surgery) plus hospital stay with daily monitoring
Duration - 12 months
Participants attend follow-up visits to assess urinary symptoms, urinary flow, residual urine volume, urinary continence, erectile function, and monitor for complications and re-interventions.
Follow-up visits at discharge and at 3, 6, and 12 months postoperatively
Trial Site Locations
Total: 1 location
1
Urologische Klinik und Poliklinik, LMU Klinikum
Munich, Bavaria, Germany, 81377
Actively Recruiting
Research Team
Y
Yannic Volz, PD Dr. med.
P
Patrick Keller, PD Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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